Device product
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
Z-1142-2023
Product summary
- Event
- Event 91506
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 71 units
- Official record key
device-enforcement:Z-1142-2023
Official wording
Reason: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
Code information: UDI 00887761978089, Serial Numbers: L1912010-050, L1905010-081, L1912010-037, L1903102-024, L1912025-024, L1903103-011, L1911019-026, L1912013-045, L1912013-036, L1905010-028, L1903102-028, L1905010-089, L1912013-019, L1903102-010, L1903103-026, L1905010-058, L1903097-007, L1903103-003, L1905010-092, L1903102-019, L1903102-013, L1904038-002, L1905010-051, L1903097-012, L1905010-018, L1904038-001, L1903103-004, L1912013-032, L1904038-003, L1911019-025, L1904050-001, L1905010-059, L1905010-088, L1911019-033, L1903103-001, L1903103-009, L1912013-013, L1903102-025, L1903103-002, L1912013-006, L1911019-010, L1912010-030, L1903097-018, L1912025-021, L1905010-004, L1903103-030, L1911019-027, L1903102-020, L1905010-041, L1912013-031, L1905010-033, L1905010-056, L1912013-041, L1905010-082, L1912010-003, L1912010-035, L1903103-014, L1912013-035, L1912010-034, L1912013-008, L1903103-027, L1903103-007, L1911019-014, L1905010-021, L1912025-019, L1903103-012, L1911019-037, L1912010-002, L1903103-010, L2001042-022, L1912025-007
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.